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Doxorubicin Injection BP by Accord

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How does Doxorubicin Injection BP by Accord work? What will it do for me?

Doxorubicin belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the family of antineoplastics called anthracyclines. Doxorubicin prevents the growth of cancer cells by interfering with the genetic material DNA, which is necessary for reproduction of cells.

Doxorubicin is used to treat many types of cancer, including cancers of the blood (e.g., leukemia), bone, breast, ovaries, testicles, thyroid, head and neck, bladder, stomach and soft tissues, Hodgkin’s disease, lung cancer, non-Hodgkin’s lymphoma, Wilm’s tumour, and neuroblastomas.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop receiving this medication without consulting your doctor.

What form(s) does Doxorubicin Injection BP by Accord come in?

Each mL of sterile, isotonic, non-preserved solution contains 2 mg of doxorubicin hydrochloride, Ph.Eur. Nonmedicinal ingredients: sodium chloride Ph.Eur., water for injection Ph.Eur., and hydrochloric acid Ph.Eur. to adjust pH to a range of 2.5-3.5.

How should I use Doxorubicin Injection BP by Accord?

The recommended dose of doxorubicin varies according to the specific condition being treated, the response to therapy, the other medications being used, and body size. Doxorubicin is usually injected into a vein through a specially prepared site on your skin.

Less often, it is administered into the bladder or into an artery. The most common dosing schedule is one dose every 21 days. Some dosing schedules call for smaller doses of the medication to be administered for 3 consecutive days every 4 weeks.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive doxorubicin, contact your doctor as soon as possible to reschedule your appointment.

Very careful handling of this medication is required. Doxorubicin should only be given by health care professionals familiar with the use of chemotherapy medications used to treat cancer. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

This medication will be stored at the hospital or clinic in the refrigerator and protected from light.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take Doxorubicin Injection BP by Accord?

Do not use this medication if you:

  • are allergic to doxorubicin, any component of the container, or any ingredients of the medication
  • are allergic to other similar cancer-fighting medications (e.g., epirubicin, daunorubicin, mitoxantrone, mitomycin)
  • have a history of severe heart disease
  • have already been treated with the maximum allowable lifetime dose of any anthracycline or anthracenedione medications (e.g., daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone)
  • have low blood cell counts caused by previous treatment with other cancer medications or radiation therapy
  • have decreased heart function
  • have severe heart rhythm problems
  • have had a recent myocardial infarction (heart attack)
  • have severe liver function impairment

In addition, doxorubicin should not be given directly into the bladder if tumours have penetrated the bladder wall, if blood in the urine or bladder infections are present, or if there is inflammation of the bladder.

What side effects are possible with Doxorubicin Injection BP by Accord?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • changes in menstrual periods
  • changes to the skin and nails
  • diarrhea
  • hot flashes
  • increased sensitivity of skin to light
  • loss of appetite
  • nausea and vomiting
  • reddish urine (not blood) – this is normal, and lasts 1 to 2 days after each dose
  • temporary total loss of hair (returns after treatments end)
  • tiredness

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • pain, redness, swelling at the place of injection
  • signs of anemia (e.g., feeling weak, dizzy, or short of breath)
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don’t stop bleeding)
  • signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, pain and swelling in one leg muscle
  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • signs of an infection (e.g., fever over 38°C, chills or sweating, sore throat, coughing, redness or swelling around a cut, wound or catheter site, painful or difficult urination, unusual vaginal itching or discharge)
  • skin rash, itching, tingling
  • sores in the mouth and on the lips

Seek immediate medical attention if any of the following occur:

  • signs of a severe allergic reaction (i.e., abdominal cramps, difficulty breathing, hives, nausea and vomiting, or swelling of the face and throat)
  • signs of digestive tract bleeding or inflammation (e.g., black, tarry stools, blood in urine or vomit, or any other unusual bleeding or bruising)
  • signs of changing heart function (e.g., fast or irregular heartbeat, shortness of breath, swelling of feet and lower legs)
  • signs of shock (e.g., cold, clammy skin; rapid, shallow breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Doxorubicin Injection BP by Accord?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor if you see any signs that your blood is not clotting as quickly as normal. Symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won’t stop bleeding.

Fertility: Doxorubicin can cause changes to sperm in men and may cause ovulation to stop during treatment in women. Both men and women appear to regain fertility after doxorubicin treatment is complete. Women and men receiving doxorubicin should use effective birth control methods.

Heart problems: This medication increases the risk of heart problems such as abnormal heart rhythm, congestive heart failure, and a weakened heart (cardiomyopathy). Some of these problems occur early in treatment, while others occur later in treatment. People with existing heart disease, those who have had radiotherapy, people who have been treated with this medication in the past, and people who are taking certain medications that act on the heart are more at risk of these problems. Your doctor will monitor you closely for these problems.

Infection: As well as killing cancer cells, doxorubicin can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor if you begin to notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do regular blood tests to monitor the number of specific types of blood cells in your blood.

Liver function: Decreased liver function or liver disease can cause this medication to build up in the body, causing side effects. People with impaired liver function may require lower doses of this medication. This medication should not be used by people who have severe liver impairment. If you have reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Secondary leukemia: There is some evidence to suggest that people who receive treatment with doxorubicin are at slightly increased risk of developing leukemia. This risk is increased when doxorubicin is given along with other anticancer medications or with radiotherapy. Talk to your doctor if you have concerns.

Tumour Lysis Syndrome: Doxorubicin, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. When this happens, you may experience nausea, shortness of breath, notice cloudy urine or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking doxorubicin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Children who receive doxorubicin are at an increased risk of developing leukemia. Children may also be more susceptible to effects of this medication on the heart.

What other drugs could interact with Doxorubicin Injection BP by Accord?

There may be an interaction between doxorubicin and any of the following:

  • abiraterone acetate
  • amiodarone
  • amphotericin B
  • apalutamide
  • aprepitant
  • azole antifungals (e.g., fluconazole, itraconazole, voriconazole)
  • BCG
  • bicalutamide
  • bosentan
  • bupropion
  • calcium channel blockers (e.g., diltiazem, verapamil)
  • carbamazepine
  • carvedilol
  • cinacalcet
  • clozapine
  • cobicistat
  • conivaptan
  • cyclosporine
  • darifenacin
  • deferasirox
  • deferiprone
  • denosumab
  • digoxin
  • dipyridamole
  • duloxetine
  • echinacea
  • elagolix
  • enzalutamide
  • fingolimod
  • flibanserin
  • grapefruit juice
  • hepatitis C antivirals (e.g., asunaprevir, daclatasvir, ledipasvir, velpatasvir)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • idelalisib
  • isoniazid
  • leflunomide
  • lomitapide
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • mefloquine
  • mifepristone
  • mirabegron
  • modafinil
  • natalizumab
  • other anthracycline cancer medications (e.g., daunorubicin, idarubicin)
  • other cancer medications (e.g., cyclophosphamide, doxetaxel, irinotecan, paclitaxel)
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • pimecrolimus
  • primidone
  • protein kinase inhibitors (e.g., crizotinib, dabrafenib, imatinib, lapatinib, nilotinib, sunitinib)
  • quinidine
  • quinine
  • rifabutin
  • rifampin
  • roflumilast
  • sarilumab
  • certain selective serotonin reuptake inhibitors (SSRI’s; e.g., fluoxetine, paroxetine, sertraline)
  • sirolimus
  • St. John’s wort
  • stiripentol
  • tacrolimus
  • ticlopidine
  • tocilizumab
  • tranylcypromine
  • tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine)
  • vaccines
  • zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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